Prabhakar Reddy, PhD, senior director, Pharmaceutical Science General Chapters & Complex Generics, USP discusses how complex formulations demand a new approach to quality and standardisation.
The future of medicines will be shaped by new molecules and the formulations that deliver them. From lipid nanoparticles (LNPs), liposomes, and long-acting injectables to inhaled therapies and drug-device combination products, today's most innovative medicines depend on increasingly sophisticated and innovative formulations. In these products, quality cannot simply be tested at the end of development; rather, quality must be designed into the product from the beginning, through robust characterisation, standardised analytical approaches, and a deep understanding of how formulation impacts performance.